Astellas Pharma, Pfizer announce FDA approval of Xtandi sNDA

Astellas Pharma (ALPMY) and Pfizer (PFE) announced that the companies received an approval by the FDA of a supplemental new drug application for Xtandi, following FDA expedited development and review programs, based on results from the Phase 3 EMBARK trial. With this approval, Xtandi becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer, or nmCSPC, with biochemical recurrence at high risk for metastasis. Patients with nmCSPC with high-risk BCR may be treated with Xtandi with or without a gonadotropin-releasing hormone analog therapy.